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U.S. Department of Health and Human Services

Class 2 Device Recall BD BACTEC FX 40 instrument

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  Class 2 Device Recall BD BACTEC FX 40 instrument see related information
Date Initiated by Firm December 09, 2013
Date Posted January 30, 2014
Recall Status1 Terminated 3 on August 20, 2014
Recall Number Z-0870-2014
Recall Event ID 67245
510(K)Number K915796  
Product Classification System, blood culturing - Product Code MDB
Product BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152.

The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
Code Information Catalog number 442296
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Ms. Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall		 Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action BD Diagnostics initiated a field correction by phone on December 9, 2013, to affected customers and followed the calls with letters, e-mails, or fax. BD Diagnostics sent a secondary Urgent Field Corrective Action letter dated November 2013 to all affected customers. The recalling firm Secondary notifications were serial number specific and explained that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights which should appear yellow may instead appear more green in color. BD noted that affected instruments continue to function properly and will not report an incorrect result. The issue is limited to the yellow indicator lights only. Red and green indicator lights appear as intended. BD is developing software to correct this issue and anticipates that the new software will be available to begin instrument updates by February, 2014. The new software will not affect instrument if the indicator lights are functioning as intended. Until the software can be updated on your instrument, BD provided workflow instructions to ensure that the indicator light issue does not occur. For questions regarding this recall call 410-316-4054.
Quantity in Commerce 2 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MDB and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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